MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 ALTRX +4 NEUT 40IDX62OD; HIP POLY ACETABULAR LINERS

Catalog Number	122140462
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Weakness (2145); Joint Dislocation (2374)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Alleges pain, fatigue, muscle weakness, difficulty walking and standing.After review of medical records for mdr reportability it was reported that the patient was revised to address recurrent dislocation.Revision note states, there was evidence of previous posterior dislocation with a large amount of hemarthrosis in and around the joint.Assessment of the acetabulum revealed that indeed the positioning of the cup was slightly under anteverted, especially given his history of back fusion.Doi: cup (b)(6) 2010.Doi: liner and head (b)(6) 2017 : dor: (b)(6); 2017 (left hip re-revision).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX +4 NEUT 40IDX62OD
• Common Device Name: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7269459
• Report Number: 1818910-2018-53385
• Device Sequence Number: 16475932
• Product Code: LPH
• UDI-Device Identifier: 10603295393535
• UDI-Public: 10603295393535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 122140462
• Device Lot Number: C72309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109